Glutamine and Traumatic Brain Injury
Primary Purpose
Brain Injuries, Traumatic
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Glutamine
Placcebo
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injuries, Traumatic
Eligibility Criteria
Inclusion Criteria:
- 18 to 60 years old
- mild to moderate head trauma
Exclusion Criteria:
- patients with concurrent cns dysfunction
- Renal failure patient
- diabetic patients with neuropathy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Glutamine group
Placcebo group
Arm Description
30 patients will recieve .3 mg/kg of glutamine for first 7 days in ICU
30 patients will recieve placcebo for first 7 days in ICU
Outcomes
Primary Outcome Measures
The duration of ICU stay
The duration of ICU stay after glutamine adiminstration
Secondary Outcome Measures
Consiousness level by Glagow coma scale
Glasgow coma scale improvement
The incidence of Convulsions
Convulsions controled by glutamine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05569993
Brief Title
Glutamine and Traumatic Brain Injury
Official Title
Does Glutamine Therapy Have a Positive Effect on Traumatic Brain Injury Patients?Double Blinded Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 30, 2022 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Glutamate is an important neurotransmitter present in over 90% of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system.
Glutamate is a non-essential amino acid with restricted passage to the brain from the blood. In the CNS, glutamate is synthesised in neurons as part of the glutamate-glutamine cycle.5,6 so it plays an essential role in normal brain functioning and can improve situations related to impaired cognitive,motor and emotional functions and can be used to improve traumatic brain injury patient general health status
Detailed Description
The term "brain injury" covers a wide range of conditions and injuries relating to the brain, skull, and scalp. A traumatic brain injury (TBI) usually results when the head or body suffers from a violent blow or jolt that results in swelling, bruising, bleeding, or tearing of the brain tissue which any damage to it has the potential to change the way your body operates.
Now ,(TBI) is considered one of the major causes of disability and deaths ,As It contributes more than 30% Of deaths worldwide . Those who survive a TBI can face effects that last a few days, or the rest of their lives. Effects of TBI can include impaired motor, cognitive and emotional functioning. These issues not only affect individuals but can have lasting effects on families and communities.TBI can also cause some inflammatory mediators to be released in circulation that affect brain and systemic organs such as cortisol,IL6 and TNF etc. A lot of modialities have been introduced to help in decreasing these side effects.
Glutamine,a non-essential amino acid present abundantly throughout the body and is involved in many metabolic processes. It is synthesized from glutamic acid and ammonia. It is the principal carrier of nitrogen in the body and is an important energy source for many cells.glutamine has a restricted passage to the brain from blood but it is synthesised in the brain as a part of the glutamate-glutamine cycle.5,6 so it present in over 90% of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system,maintaining normal brain function and can improve situations related to impaired cognitive,motor and emotional functions.
Hypothesis of this study; Does glutamine therapy have a positive effect on traumatic brain injury patients ?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
2 groups will recieve glutamine ,the other will be placcebo group
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Double blinded clinical trial Masking for patient,their relatives and outcome assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glutamine group
Arm Type
Active Comparator
Arm Description
30 patients will recieve .3 mg/kg of glutamine for first 7 days in ICU
Arm Title
Placcebo group
Arm Type
Placebo Comparator
Arm Description
30 patients will recieve placcebo for first 7 days in ICU
Intervention Type
Drug
Intervention Name(s)
Glutamine
Intervention Description
.3 mg/kg of glutamine
Intervention Type
Other
Intervention Name(s)
Placcebo
Intervention Description
Patients will recieve placcebo
Primary Outcome Measure Information:
Title
The duration of ICU stay
Description
The duration of ICU stay after glutamine adiminstration
Time Frame
First 30 days
Secondary Outcome Measure Information:
Title
Consiousness level by Glagow coma scale
Description
Glasgow coma scale improvement
Time Frame
30 days
Title
The incidence of Convulsions
Description
Convulsions controled by glutamine
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 to 60 years old
mild to moderate head trauma
Exclusion Criteria:
patients with concurrent cns dysfunction
Renal failure patient
diabetic patients with neuropathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Engy Raafat Youssif, Master student
Phone
01226016909
Email
Engiraafat95@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Hassan Bakri, Professor
Organizational Affiliation
Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Emad Zarief Kamel, Assistant professor
Organizational Affiliation
Assiut University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.mayoclinic.org/diseases-conditions/traumatic-brain-injury/symptoms-causes/syc-20378557&ved=2ahUKEwj03c7No736AhWJgP0HHWbdB_AQFnoECAsQAQ&usg=AOvVaw1hApNyp5Z15Rb6ZV9Bsz6j
Description
Related Info
URL
https://www.google.com/url?sa=t&source=web&rct=j&url=https://my.clevelandclinic.org/health/articles/22839-glutamate&ved=2ahUKEwj6lYmLpb36AhV0hv0HHXvCBlYQFnoECCsQAQ&usg=AOvVaw0I8zh85AIWxxVmICDoKYAD
Description
Related Info
URL
https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.frontiersin.org/articles/10.3389/fnhum.2021.722323/full&ved=2ahUKEwj6lYmLpb36AhV0hv0HHXvCBlYQFnoECDAQAQ&usg=AOvVaw1Tp_hCCgkjNJLx_761AVQx
Description
https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4133642/&ved=2ahUKEwj6lYmLpb36AhV0hv0HHXvCBlYQFnoECEIQAQ&usg=AOvVaw1_kGwGwx5h2G2svqnAp1SJ
URL
https://www.google.com/url?sa=t&source=web&rct=j&url=https://medlineplus.gov/traumaticbraininjury.html&ved=2ahUKEwik8NOwpb36AhVUgP0HHZ9xDvQQFnoECEQQAQ&usg=AOvVaw1xT2gGMsCPiHuu0ZAFDDID
Description
Related Info
Learn more about this trial
Glutamine and Traumatic Brain Injury
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